United States Patent 9,119,848: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,119,848, assigned to Alkermes Inc., is a significant patent in the pharmaceutical industry, particularly for the drug LYBALVI® (olanzapine and samidorphan). This patent is crucial for understanding the intellectual property landscape surrounding this medication, which is used for the treatment of schizophrenia and bipolar I disorder.
Background of LYBALVI®
LYBALVI® is a combination drug consisting of olanzapine and samidorphan, approved by the FDA for the treatment of schizophrenia in adults and bipolar I disorder, including acute treatment of manic or mixed episodes and maintenance monotherapy treatment[4].
Patent Overview
Patent Number and Title
The patent in question is U.S. Patent No. 9,119,848. The title of the patent is related to the L-malate salt of samidorphan, one of the active ingredients in LYBALVI®.
Claims
The patent claims the L-malate salt of samidorphan, which is a critical component of LYBALVI®. The claims are specific to the chemical composition and the method of preparation of this salt, ensuring that Alkermes Inc. has exclusive rights to this particular formulation[2].
Scope of Protection
The scope of protection for this patent includes the specific chemical entity (L-malate salt of samidorphan) and its use in the formulation of LYBALVI®. This protection prevents other companies from manufacturing, using, or selling this exact formulation without permission from Alkermes Inc.
Patent Landscape
Regulatory Review and Approval
The approval of LYBALVI® involved a lengthy regulatory review period. The FDA determined that the regulatory review period for LYBALVI® was 4,564 days, which includes both the testing phase and the approval phase. This period is significant for calculating any potential patent term extensions[4].
Patent Term Extension
Alkermes Inc. has applied for patent term extensions for several patents related to LYBALVI®, including U.S. Patent No. 9,119,848. The USPTO and FDA collaborate to determine the eligibility and duration of these extensions, which can significantly impact the patent's lifespan[4].
Related Patents
LYBALVI® is protected by multiple patents, including U.S. Patent Nos. 7,262,298, 9,126,977, 10,300,054, and 10,716,785. These patents collectively cover various aspects of the drug, such as different formulations, methods of use, and manufacturing processes[4].
Impact on the Pharmaceutical Industry
Market Exclusivity
The patent protection for LYBALVI® grants Alkermes Inc. market exclusivity for the specific formulation covered by the patent. This exclusivity is crucial for the company's revenue and competitive advantage in the market.
Innovation and Research
Patents like U.S. Patent No. 9,119,848 encourage innovation by providing a financial incentive for companies to invest in research and development. The protection offered by these patents allows companies to recoup their investment and continue developing new treatments.
Challenges and Controversies
Patent Term and Extension
The process of determining patent term extensions can be complex and contentious. Interested parties may petition the FDA to review the dates and diligence of the applicant during the regulatory review period, which can affect the final extension granted[4].
Generic Competition
Once the patent expires, generic versions of the drug can enter the market, potentially reducing the market share and revenue of the original patent holder. Companies often seek patent term extensions to delay this competition.
Key Takeaways
- Patent Scope: U.S. Patent No. 9,119,848 specifically covers the L-malate salt of samidorphan, a key component of LYBALVI®.
- Regulatory Approval: The FDA approval process for LYBALVI® involved a lengthy regulatory review period, which is crucial for determining patent term extensions.
- Market Impact: The patent provides Alkermes Inc. with market exclusivity, protecting their investment in research and development.
- Challenges: The patent term extension process can be complex, and generic competition is a significant concern once the patent expires.
FAQs
What is the main subject of U.S. Patent No. 9,119,848?
The main subject of U.S. Patent No. 9,119,848 is the L-malate salt of samidorphan, an active ingredient in the drug LYBALVI®.
What is LYBALVI® used for?
LYBALVI® is used for the treatment of schizophrenia in adults and bipolar I disorder, including acute treatment of manic or mixed episodes and maintenance monotherapy treatment.
How long was the regulatory review period for LYBALVI®?
The regulatory review period for LYBALVI® was determined to be 4,564 days by the FDA.
Can other companies manufacture LYBALVI® while the patent is in effect?
No, other companies cannot manufacture, use, or sell the exact formulation of LYBALVI® covered by U.S. Patent No. 9,119,848 without permission from Alkermes Inc.
What happens when the patent for LYBALVI® expires?
Once the patent expires, generic versions of the drug can enter the market, potentially reducing the market share and revenue of Alkermes Inc.
Sources
- The Feasibility of Using Bayh-Dole March-In Rights to Lower Drug Prices - National Bureau of Economic Research.
- US Patent No. - Regulations.gov - U.S. Government Publishing Office.
- Synthetic Biology - Mapping the Patent Landscape - bioRxiv.
- Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Notices - U.S. Government Publishing Office.
- Patent Extension Application for LYBALVI® (olanzapine and samidorphan), Patent No. 9,119,848 - Regulations.gov.
